Recruiting

tDCS

Sponsor:

Women's College Hospital

Code:

NCT05097586

Conditions

Major Depression

Pregnancy

Postpartum Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

active tDCS

workbook

sham tDCS

Study Details

Brief summary:

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

Conditions

Major Depression

Pregnancy

Postpartum Depression

Study ID

NCT05097586

Start date

Nov 8, 2021

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Adult, ≥18 years of age
2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
3. In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)
4. Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use
5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment

Exclusion criteria:

1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
5. Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia/eclampsia in current pregnancy or neurologic illness or seizure history
6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
7. Metal implants in cranium or any electrical implants
8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS
9. Visibly non-intact skin/rash on scalp areas at stimulation electrode sites
10. Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active tDCS

2mA of direct current delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.

sham comparator: control

Sham stimulation where the current is turned off after 30 seconds in a slow ramp down, delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.

Interventions

active tDCS

2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks

workbook

Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state

sham tDCS

Sham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks

Primary outcome measure

  • Depressive symptoms post treatment [ Time Frame: End of Week 3 of treatment ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Sophie Grigoriadis, MD

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S1B2

Contacts

Principal Investigator:

Simone Vigod

More Information

Sponsor

Women's College Hospital

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Keywords

  • Pregnancy
  • Depression
  • Transcranial direct current stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2026-08-10.